FDA is looking closely at anemia drug evidence

WASHINGTON The Food and Drug Administration is questioning the evidence used to support an anemia drug made by Amgen and Johnson & Johnson. Anemia is a deficiency of red blood cells.

The FDA has said it found "important deficiencies" in material that is being used to prove the drugs improve quality of life for anemic kidney disease patients by boosting their energy. The names of the drugs are Epogen and Aranesp, manufactured by Amgen and Procrit by Johnson and Johnson.

The agency is also questioning the proper dosage for the drugs when given to patients who are suffering from kidney failure. High doses of the drugs have been linked to cardiovascular and cancer-related risks.

Medicare will be watching this outcome closely as they have also expressed concerns regarding dosages and are stating that they will limit coverage depending on dosage requirements.

SPECIAL REPORTS

It’s done. A hearing aid category specific to the over-the-counter arena was signed into law in August; all that remains to be created is the regulatory framework. Read more in this special report. Read more...

IN THIS ISSUE

Drug Store News shares exclusive highlights from the CVS Health Leadership Summit about the company’s efforts to speed up healthcare innovation; highlights the sleep and homeopathy categories’ continued growth; showcases the growing role of pharmacy technology; and more! Read more...